Public policy coverage and access to medicines in Brazil

ABSTRACT OBJECTIVE Describe consumption patterns for monetary and non-monetary acquisition of medicines according to age and income groups, highlighting pharmaceuticals associated with health programs with specific access guarantees. METHODS Descriptive observational study using microdata from the 2017–2018 Pesquisa de Orçamentos Familiares (Household Budget Survey, POF/IBGE). We initially reviewed programs/policies with specific guarantees of access to medicines in the SUS. Using the pharmaceutical product list of POF-4 (chart 29 of the questionnaire on individual expenditures), we selected the medicines related to these programs. We then described frequencies and percentages for not reporting medicine consumption and for reporting consumption (either through monetary or non-monetary acquisition) according to age and income groups. For medicines with distinctive access guarantees, we compared average monthly values of acquisitions and consumption patterns by age and income. RESULTS 63% of those in the ≤ 2 minimum wage (MW) household income group did not report consuming medicines in the last month. Among those earning > 25 MW, 44.3% did not report consumption. Non-monetary acquisitions of medicines were mainly reported for the < 10 MW group and for the elderly and accounted for 20.5% of the total consumption of medicines (in value). For policies with specific access guarantees, non-monetary acquisitions reached 33.6% of total consumption. This percentage varied for the various selected medicines: vaccines, 83.3%; cancer drugs, 70.3%; diabetes, 47.9%; hypertension, 35.9%; asthma and bronchitis, 29.2%; eye problems, 14%; prostate and urinary tract, 10.7%; gynecological, 11.6%; and contraceptives, 9.7%. CONCLUSION Shares for non-monetary acquisitions of medicines are still low but benefit mainly lower-income and older age groups. Policies and programs with specific access guarantees to medicines have increased access. Results suggest the need to strengthen and expand pharmaceutical care policies.


INTRODUCTION
Pharmaceuticals are a significant component of the global health spending. Among Organization for Economic Cooperation and Development (OECD) member countries, they account for 20% of total health expenditures 1 . In Brazil, they account for 18.4% of the country´s expenditures on health goods and services, and for 29.2% of household health expenditures 2 , especially compromising the most vulnerable 3 . This highlights the importance of public funding in access to medicines.
Public policies on pharmaceutical coverage are defined according to their breadth, scope, and depth (whether copayment is required to obtain medicines) 4 . Pharmaceutical market regulatory and pricing policies 3,5 determine expenditures incurred by households and, ultimately, their access to medicines.
The breadth of pharmaceutical coverage defines the percentage of the population having access via public funding. OECD countries usually provide comprehensive coverage for medicines through government reimbursement schemes or specific insurance schemes 6 . Restrictions concern the scope of medicines available (positive and negative lists for government funding) 7 and whether copayment is required 6 . Emerging countries, on the other hand, do not provide full public coverage. In practice, they restrict public funding to specific demographic or population segments or diseases, with a limited scope of medicines available 4 .
In Brazil, the Política Nacional de Medicamentos (PNM -National Medicine Policy) and the Política Nacional de Assistência Farmacêutica (PNAF -National Pharmaceutical Care Policy), issued in 1998 and 2004, respectively, established guidelines and strategic axes to secure access to medicines and to promote their rational use. They also defined the Relação Nacional de Medicamentos Essenciais (Rename -National List of Essential Medicines) 8,9 . As of 2012, the Rename lost its role in guiding public supply of medicines and started being considered a positive list for public funding by the three spheres of government 10 .
In addition to the expectation of securing access to medicines in the Rename, the Brazilian National Health System (SUS) has organized its pharmaceutical care (PC) around several programs and policies targeting specific population segments or diseases. These include, in variably explicit ways, distinctive guarantees of access to medicines. Mapping the policies that provide these distinctive guarantees is a good starting point to monitor performance in this area.
Nationwide studies on the extent of pharmaceutical coverage in Brazil are scarce. Data on public procurement may be obtained from government administrative records and used to produce information on the availability of medicines. There are significant gaps in these data, notably regarding purchases by states and municipalities. In addition, data lack information on the scope and population coverage by the PC policies.
The Pesquisa de Orçamentos Familiares (POF -Household Budget Survey) 11 is an infrequently used source that may allow us to obtain more details on coverage by type of medicine, beneficiary and consumption (divided into monetary and non-monetary acquisitions). In addition to reporting out of pocket (OOP) expenditures on pharmaceuticals (monetary acquisitions), the POF asks respondents to estimate the monetary values of medicines obtained as non-monetary acquisitions. This provides potential information on public funding for medicines. The POF also allows us to describe the distribution of consumption by income and age groups, both for monetary and non-monetary acquisitions.
Starting by systematizing SUS programs and policies containing explicit PC guarantees, we sought to identify patterns of coverage and consumption for non-monetary acquisition by income and age groups. Understanding who benefits from non-monetary acquisitions is crucial to monitor and evaluate policy results in this area.

METHODS
This is an observational study using data from the Pesquisa de Orçamentos Familiares (POF) of the Instituto Brasileiro de Geografia e Estatística (IBGE -Brazilian Institute of Geography and Statistics). We initially reviewed the Health Legislation for laws, ordinances and norms related to health programs specifically including the provision of medicines among their objectives. We then went on to identify the main current specific guarantees of access to pharmaceutical coverage in the SUS.
The POF is a household survey with a sample of 57,920 households selected in conglomerates at the different strata of the survey. It has national representativeness and aims to describe the consumption and income patterns, as well as the living conditions of Brazilian households. Using the variables in chart 29 of the POF's individual expenditure questionnaire (Questionnaire 4), comprising 88 types of pharmaceutical products, we prepared translators to associate each of the previously identified programs with the corresponding POF's types of pharmaceutical products. Two authors -a physician and a pharmacist -selected and matched the pharmaceutical product types to the related PC programs. Both authors were seasoned in public health management.
We used the latest edition of the POF, covering from July 11, 2017 to July 9, 2018. Data on pharmaceutical products in the survey refer to those obtained in the 30 days preceding the interview.
The survey provides data on consumption expenditures and mode of acquisition (variable V9002), divided into 'monetary acquisition' and 'non-monetary acquisition' (without OOP payment by those obtaining the medicine). For the non-monetary acquisitions, respondents also report their estimated values for the medicines obtained. The POF microdata also include deflated values for the January 2018 reference period (variable V8000_defla) to prevent price variations over the data collection period from distorting the interpretation of results 11 .
For each type of pharmaceutical product listed in the POF, the number of people reporting consumption and the reported values for monetary and non-monetary acquisitions were aggregated according to age (V0403) and income groups (variable Renda_total (Total_ household_income) for those obtaining the medicine).
To check the consistency between values estimated by respondents for non-monetary acquisitions and those informed for monetary acquisitions (proxy of market prices), we calculated the average monthly values for monetary and non-monetary acquisitions for each type of pharmaceutical product.
A descriptive analysis, with one-off and interval-based estimates, was carried out for: (a) average monthly values and percentages of subjects reporting consumption; (b) total consumption of medicines; (c) percentage of subjects reporting non-monetary acquisitions among those obtaining medicines from programs with specific guarantees of access.
Variables with small frequencies in the sample were excluded from tables. Analyses were performed using the R software (version 4.0.3), and the survey package (version 4.0), which considers the sampling design of the survey. The share of subjects reporting non-monetary acquisition in total consumption was described by age and income groups. We used the svyciprop function to calculate 95% confidence intervals 12 .

RESULTS
Brazil has several health programs or policies involving specific guarantees of access to medicines. In addition to the PNM and the PNAF, which are more comprehensive, we identified those policies and programs and related them to the specific types of pharmaceutical products surveyed in the POF (Box).
When considering the universe of pharmaceutical products with data collected in the POF (and not just those with specific guarantees of access in the SUS), 63% of the ≤ 2 MWs household income group did not report obtaining medicines in the last month. In the > 25 MWs group, this percentage was 44.3% ( Figure). Consumption percentages decrease along income groups, suggesting budgetary restrictions to consumption in lower income groups and/or excessive consumption in higher income groups.
Subjects earning < 10 MWs have the greatest shares of non-monetary acquisitions. Nevertheless, shares for non-monetary acquisitions are low across all income groups, varying from 5.8% to 1.7% for exclusively non-monetary acquisition (Figure).
Starting from the 2-3 MWs group, non-monetary acquisitions -including the 'both monetary and non-monetary acquisition' category depicted in Figure -decrease as income increases. The lowest share for this compound non-monetary acquisitions is seen in the > 25 MWs group (4.5%). For the ≤ 2 MWs group, this percentage is 9.9%.
Box. Specific guarantees of access to medicines in health policies and programs, according to POF types of pharmaceutical products.

Policies/Programs
Specific guarantees of access to medicines POF pharmaceutical product type For Aids

Condom and intimate lubricant
Programa Nacional de Imunizações (National Immunization Program) Access to vaccines and serums 14,21 . Vaccines

Programas Estratégicos de Saúde (Strategic Health Programs)
There is no formal program with this denomination. It includes a set of health programs, such as control of tuberculosis, leprosy, focal endemics, flu (influenza), as well as prevention of nutritional deficiencies, and the blood and blood products program 14  Over half of pharmaceutical products listed in the POF (58.6%) are not related to any health program or policy. In this group, 11.3% of the consumption value refers to non-monetary acquisitions. The POF did not report monetary acquisitions for Aids medicines, as they are not sold at commercial pharmacies. Thus, there is no price reference for respondents in their value estimates of non-monetary acquisitions. Small samples reporting consumption of medicines for Aids, autism, alcoholism, smoking and immunosuppressants preclude a robust estimate of monthly averages for these pharmaceuticals.
Non-monetary acquisitions also had significant shares in medicines for: infectious or endemic diseases (41.5%); cholesterol-lowering (31.3%); and nervous system (30%). Contraceptives (9.7%); prostate and urinary tract medicines (10.7%); medicines for gynecological problems (11.6%); and for eye conditions (14%) hold the smallest shares for non-monetary acquisitions in total consumption. Table 3 shows the percentages of non-monetary acquisitions for medicines related to each health program or policy by age and income groups.
For most programs and policies with specific medicine guarantees, differences between age groups were not significant. Sample size did not allow disaggregation by age and income in some cases. Table 2. Monthly monetary and non-monetary consumption of medicines with specific guarantees provided, in amount (R$ million) and number of subjects obtaining them (in thousands) (95%CI).  Income groups in the 0-15 MWs range reported higher percentages of non-monetary acquisitions for the programs studied, with the exception of medicines related to the Política Nacional de Atenção em Oftalmologia (National Eye Care Policy), with a confidence interval too wide to support this conclusion. Households with incomes > 15 MWs showed lower shares of non-monetary acquisitions for medicines (Table 3).

DISCUSSION
Non-monetary acquisition by households accounted for 20.5% of the total value of pharmaceutical consumption in the POF. The highest shares for non-monetary acquisitions were reported by households in the < 10 MW income groups and for older age groups. The share of public funding in pharmaceutical consumption is notoriously low in Brazil, far below the OECD average of 58% 23 .
In the Conta-Satélite de Saúde (Brazilian Health Satellite Accounts) 2 , an IBGE publication with aggregate data for health-related goods and services, non-monetary medicine consumption by Brazilian households represented 7.5% of total pharmaceutical consumption. The main reason for the difference in non-monetary consumption between the POF and the Conta-Satélite concerns prices and the type of pharmaceutical purchased by the government. The government provides medicines based on medical prescriptions and rational use. It also buys in larger scale and pays lower prices comparatively to households, as it uses the Preços Máximos de Venda Governamental (Government Maximum Sales Prices), which are below market prices in some cases. Thus, with equal resources, the government will buy more units of pharmaceuticals than households. On assuming similar prices for monetary and non-monetary acquisitions, one could say that the POF's percentage for non-monetary Table 3. Non-monetary acquisitions as shares (%) of consumption for medicines with specific guarantees of access, according to policy or program, age and income (in minimum wages) groups (95%CI). Non-monetary access to medicines for hypertension and diabetes via the Programa Farmácia Popular prevented hospitalizations in the SUS, and deaths related to these diseases in the municipalities hosting the program 25 . The free availability of medicines in Programa Farmácia Popular and the end of copayment increased their use. This suggests that, for many people, price is a barrier to access, even if products are dispensed in pharmacies of the SUS health units 26,27 .

Programa Nacional de Imunizações
Lower income groups obtain medicines by non-monetary means more often than higher income groups. As price is a more frequent barrier to access 26 for them, obtaining medicines at no cost prevents the worsening of health status, potential hospitalizations and early death due to interruptions in treatment of previously diagnosed chronic diseases 25 .
This implies that the decrease in public funding for medicines reported in administrative records since 2016 may have grave effects both on population health and on expenditure on services, overloading the hospital network with preventable cases 25 .
Women's care was the PC-sponsored program with lowest coverage. This was a surprising finding considering the prominence of this policy segment, related to goals 3 and 5 of the Sustainable Development Goals (SDG) 28 . Policies on men's health care, eye care, and tobacco control also recorded low shares for non-monetary acquisition of medicines. Among the more recent policies, OOP values required to buy some medications with low prices in private pharmacies, such as contraceptives, may be one of the reasons for the low coverage seen for these policies. High prices and low barriers to access in SUS probably act as incentives for seeking medicines through public provision. Complexity in procedures to obtain these medicines may discourage this demand, specially burdening those with lower income. This suggests a need to simplify the procedures for medicine obtention for products reporting low shares of non-monetary acquisitions, as in the case of contraceptives.
The good coverage for the so-called 'poverty medicines' (vaccines and endemic diseases) draws attention. These products focus on communicable diseases and imply the oldest specific guarantees in PC, as the Programa Nacional de Imunizações preceded the PNAF 29 .
This study has some limitations. For the very advanced ages, small sample size leads to frail estimates, given data variability. For less-used medicines (such as for smoking or cancer), small samples produce large variances preventing meaningful analyses by age or income groups.
There are also differences between POF results for non-monetary acquisition of medicines and government administrative records for expenditures in specific programs, such as for Aids. This limitation of the database reflects the estimation of non-monetary acquisition values by POF respondents and the small sample sizes for medicines used by a small part of the population.
The survey does not record medicine acquisition by under-10-year-olds. It also reports acquisition and not actual use of the medication. So one can presume that the acquisitions made for use of younger age groups are largely made by their parents and recorded as parental acquisitions. This leads to potential overestimation of consumption for groups in charge of children or minors.
The distribution of free samples of medicines 30 and, since 2014, the provision of oral antineoplastics and medicines for chemotherapy side effects by health plans 31 need to be acknowledged, as they may account for part of the non-monetary acquisitions. It would be thus incorrect to suppose that all non-monetary medicine acquisitions in the POF reflect SUS funding.
Estimation of values for non-monetary acquisitions by POF respondents has generated some mistrust regarding data, and could be considered a limitation. However, on comparing average monthly values for monetary and non-monetary acquisitions of the selected pharmaceuticals in our study no substantial differences were found. This strengthens the case for the use of these data. The use of POF non-monetary acquisition data is one of the positive contributions of this article to the study of PC coverage.
The policies and programs highlighted in this study provide specific medicines to their beneficiaries. It should be remembered, however, that the right to comprehensive therapeutic care is an integral part of the right to health. To ensure it, central and sub-national governments in Brazil have implemented several measures to strengthen PC in the SUS. A large network of public pharmacies is responsible for delivering PC throughout the country. However, the low availability of medicines in these pharmacies 32 may partly explain the high percentage of monetary acquisitions for highly prevalent diseases, even when additional guarantees defined in specific policies and programs are in place. This suggests the existence of barriers to access to these products in the SUS.
The results of this article suggest the need to strengthen and expand PC policies. They have mainly benefited groups with lower income or higher age-related consumption. Data on monetary and non-monetary medicine acquisitions provided in the POF, albeit indirectly, help to describe the scope of these policies regarding access to medications.